MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP AUTO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 760P

Device Problem Fire (1245)

Patient Problem Death (1802)

Event Date 11/15/2015

Event Type  Death  

Event Description

The manufacturer received information that a death occurred in a user's home during a fire.The origin of fire is alleged to have been "in the area of a bipap system 1 and humidifier system 1" devices.The manufacturer was not provided serial numbers or catalog numbers of the devices reportedly in the home at the time of the event.The manufacturer's investigation is on-going.Upon completion of the investigation, a follow up report will be filed.

Manufacturer Narrative

The manufacturer made numerous requests for the return of the device for investigation.No product was returned.The serial number of the bipap was made available, and a review of the device history record indicates there were no operational issues noted at the time of manufacture.Copies of official reports from the (b)(6) state fire marshall, the (b)(6) police department, and fire investigation task force were provided to the manufacturer.Although the exact cause of death was not determined, it is indicated in the reports that there was an oxygen concentrator in the area of the fire and the bipap, and that the user was known to smoke cigarettes while using supplemental oxygen.The manufacturer of the oxygen concentrator is unknown.Based on the available information, the manufacturer concludes no further action is necessary.

• Brand Name: BIPAP AUTO
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: wilfredo alvarez ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 5334339
• MDR Text Key: 34655784
• Report Number: 2518422-2015-04344
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 760P
• Device Catalogue Number: 760P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death